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In a highly speculative piece the New York Times suggests that a possible change in labeling requirements risks generic drug makers being sued link here. This comes just two years after the Supremes decided the reverse i.e., that they couldn't be sued as the law required they use the same warning label as the brand-name makers (see our piece posted on 06/26/2013 at 08:40 AM.

Apparently the change is prompted by the FDA's discovery that users harmed by a generic drug should be able to sue if their drug fails to perform correctly.

This all seems a stretch. The warning labels are framed based on what is known at the time it is approved. Subsequent experience could quite reasonably have shown the need for amending approved uses and thus, labeling. Like most of us, when the facts change, the FDA changes its opinion or so we can hope.

Comments

John Bennett: One portion of your post is imprecise.

You state that "warning labels are framed based on what is known at the time it [the drug] is approved." That statement is imprecise, at best. After a drug is released by the FDA for use by the public, if the patent holder is aware of potential side effects, the patent holder is required by law to update the drug labeling. Thus, the drug label in fact changes with time.

However, generic manufacturers are not bound by any such requirement. Thus, if a generic manufacturer learns of a hazardous side effect, they are not required to update the warning label. The situation becomes potentially dangerous to the public when the original patent holder leaves the market. At that point, no one is responsible for updating warning labels and there is no mechanism for updating warning labels.

It is true that by changing the rule the FDA could be opening generic manufacturers to potential lawsuits. However, by not changing the rule, the public may be placed in danger. Which approach is ultimately in the best interest of the public? Your statement indicates that you think they public is just going to have to suffer through as best as they can without knowing about all the dangers a drug might present. That seems unfair.

It seems reasonable to place primary burden on maintaining warning labels on the original patent holder during the life of a patent. After all, the patent holder gains from having the patent, so they should also bear the responsibility. Once the patent holder leaves the market, the generic manufacturers need to take the responsibility to the safety of the drug, even if it increases the costs of generic drugs.